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Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Hyperlipidemia or Mixed Dyslipidemia at Risk of Cardiovascular Events (SPIRE-LDL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968967
First Posted: October 24, 2013
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: June 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hyperlipidemia
Interventions: Drug: Bococizumab (PF-04950615; RN316)
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was conducted from 29 October 2013 to 05 July 2016 at multiple sites.

Reporting Groups
  Description
Placebo Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
Bococizumab (PF­-04950615) 150 Milligram (mg) Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.

Participant Flow:   Overall Study
    Placebo   Bococizumab (PF­-04950615) 150 Milligram (mg)
STARTED   1071   1068 
Treated   1065   1063 
COMPLETED   925   934 
NOT COMPLETED   146   134 
Other                22                22 
Withdrawal by Subject                71                61 
Did Not Meet Entrance Criteria                2                3 
Lost to Follow-up                26                31 
Protocol Violation                1                2 
Adverse Event                9                8 
Death                9                2 
Randomized Not Treated                6                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all participants who were randomized.

Reporting Groups
  Description
Placebo Participants received placebo matched to Bococizumab (PF-­04950615) subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
Bococizumab (PF­-04950615) 150 mg Participants received Bococizumab (PF­-04950615) 150 mg subcutaneous injection once every 2 weeks up to Week 52. Participants were followed up to 58 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   Bococizumab (PF­-04950615) 150 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 1071   1068   2139 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (9.8)   61.8  (9.3)   62  (9.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      434  40.5%      434  40.6%      868  40.6% 
Male      637  59.5%      634  59.4%      1271  59.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Percent Change From Baseline in Fasting Total Cholesterol (TC) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

3.  Secondary:   Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

4.  Secondary:   Percent Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

5.  Secondary:   Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides (TG) Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

6.  Secondary:   Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

7.  Secondary:   Percent Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

8.  Secondary:   Percent Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

9.  Secondary:   Percent Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 24 and 52   [ Time Frame: Baseline, Week 24, 52 ]

10.  Secondary:   Percent Change From Baseline in Fasting Triglycerides (TG) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

11.  Secondary:   Percent Change From Baseline in Fasting Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

12.  Secondary:   Percent Change From Baseline in Fasting Apolipoprotein A-II (ApoA-II) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

13.  Secondary:   Percent Change From Baseline in Fasting Very Low Density Lipoprotein Cholesterol (VLDL-C) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

14.  Secondary:   Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Less Than (<) 200 Milligram Per Deciliter (mg/dL) at Week 12   [ Time Frame: Baseline, Week 12 ]

15.  Secondary:   Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) by Triglycerides Cut-off of Greater Than or Equal to (>=) 200 Milligram Per Deciliter (mg/dL) at Week 12   [ Time Frame: Baseline, Week 12 ]

16.  Secondary:   Absolute Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline, Week 12 ]

17.  Secondary:   Absolute Change From Baseline in Fasting Total Cholesterol (TC) at Week 12   [ Time Frame: Baseline, Week 12 ]

18.  Secondary:   Absolute Change From Baseline in Fasting Non High Density Lipoprotein Cholesterol (HDL-C) at Week 12   [ Time Frame: Baseline, Week 12 ]

19.  Secondary:   Absolute Change From Baseline in Fasting Apolipoprotein B (ApoB) at Week 12   [ Time Frame: Baseline, Week 12 ]

20.  Secondary:   Absolute Change From Baseline in Fasting Lipoprotein (a) (Lp[a]) at Week 12   [ Time Frame: Baseline, Week 12 ]

21.  Secondary:   Absolute Change From Baseline in Fasting High Density Lipoprotein Cholesterol (HDL-C) at Week 12   [ Time Frame: Baseline, Week 12 ]

22.  Secondary:   Absolute Change From Baseline in Ratio of Fasting Total Cholesterol (TC) to High Density Lipoprotein Cholesterol (HDL-C) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

23.  Secondary:   Change From Baseline in Ratio of Fasting Apolipoprotein B (ApoB) to Apolipoprotein A-I (ApoA-I) at Week 12, 24 and 52   [ Time Frame: Baseline, Week 12, 24, 52 ]

24.  Secondary:   Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 100 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52   [ Time Frame: Week 12, 24, 52 ]

25.  Secondary:   Percentage of Participants Achieving Fasting Low Density Lipoprotein Cholesterol (LDL-C) Less Than or Equal to (<=) 70 Milligram Per Deciliter (mg/dL) at Week 12, 24 and 52   [ Time Frame: Week 12, 24, 52 ]

26.  Secondary:   Plasma Concentration of PF-04950615 at Week 12, 24 and 52   [ Time Frame: Week 12, 24, 52 ]

27.  Secondary:   Number of Participants With Adverse Events (AEs) Related to Type 1 or 3 Hypersensitivity Reactions and Injection Site Reactions   [ Time Frame: Baseline up to end of study (up to Week 58) ]

28.  Secondary:   Percentage of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibodies (nAb)   [ Time Frame: Baseline up to end of study (up to Week 58) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01968967     History of Changes
Other Study ID Numbers: B1481020
2013-002643-28 ( EudraCT Number )
SPIRE-LDL ( Other Identifier: Alias Study Number )
First Submitted: October 21, 2013
First Posted: October 24, 2013
Results First Submitted: June 22, 2017
Results First Posted: July 24, 2017
Last Update Posted: August 21, 2017